‘Non-Starter’ to Authorize COVID-19 Vaccine for Infants: Dr. Peter McCullough
Moderna has requested the U.S. Food and Drug Administration (FDA) to grant an emergency use authorization (EUA) for its COVID-19 vaccine for children as young as 6 months. However, according to Dr. Peter McCullough, such authorization shouldn’t be granted because there’s almost no clinical benefit for children that young.
Pfizer is also working on data for a three-dose regimen after the FDA postponed its decision in February on whether to authorize its COVID-19 vaccine for this age group.
“I think for children that age, it’s a non-starter,” McCullough told NTD’s “Capitol Report” program on April 30.
McCullough said a recent study from New York State showed the efficacy of Pfizer’s COVID-19 vaccine in young children was so low that “it looks like they don’t work.”
The study (pdf) analyzed the Pfizer vaccine’s effectiveness in over 1.2 million fully vaccinated children in New York state from Dec. 13, 2021, to Jan. 30, 2022. Among those vaccinated children, over 852,000 were aged 12–17, and over 365,000 were aged 5–11.
“In the papers by [Vajeera] Dorabawila and colleagues from New York state, over a couple hundred thousand children aged 5 to 11, [had] virtually no clinical benefit, no vaccine efficacy. All the vaccine efficacy was less than 25 percent,” said McCullough, a renowned cardiologist and epidemiologist.
The study found that the vaccine effectiveness against infection declined from 66 percent to 51 percent for 12 to 17-year-olds and from 68 percent to 12 percent for 5 to 11-year-olds in about one and a half months.
The Pfizer vaccine is the only one currently being administered to children in this age group.
The FDA has said that vaccines should be at least 50 percent effective in preventing infection or decreasing disease severity to receive emergency authorization. The World Health Organization says vaccines are required to be 50 percent effective or better to receive clearance.
According to Moderna’s data, the vaccine was just 43.7 percent effective in the youngest group and 37.5 percent effective in the other children during the Omicron wave. Both were below the 50 percent bar. Some doctors and experts questioned that the trial result was not strong enough to warrant a EUA.
“That’s not acceptable by the FDA’s own standards,” Dr. Steven Hatfill, a virologist who advised the Trump administration, told The Epoch Times last month.
The FDA said it would thoroughly review Moderna’s request after additional data was provided.
“We have received a request from Moderna for a EUA for its COVID-19 vaccine for children 6 months to 6 years of age. As the company has acknowledged, they still need to submit additional data to complete its request. FDA cannot reach a decision on any vaccine without a completed EUA request, which allows us to do a thorough review, which includes, among other things, a comprehensive review of all of the adverse events and replication of the key analyses,” an FDA spokesperson told The Epoch Times in an email last week.
Some experts said it doesn’t make sense for young children to receive COVID-19 vaccines, as they are at low risk for severe disease and death from the CCP (Chinese Communist Party) virus, and the possible severe side effects are a big concern.
“Parents should think twice about vaccinating their child,” Dr. Robert Malone previously told The Epoch Times, adding that serious adverse events can occur, and most “are irreversible.”
Malone is a key contributor to mRNA vaccines, and his website includes a list of peer-reviewed studies related to COVID-19 vaccine adverse events in children, the main one being myocarditis.
In March, Florida’s top health official issued guidance, saying healthy children may not benefit from receiving current COVID-19 vaccines.
“Based on currently available data, the risks of administering COVID-19 vaccination among healthy children may outweigh the benefits,” Florida Surgeon General Dr. said in a statement. “That is why these decisions should be made on an individual basis and never mandated.”
The Centers for Disease Control and Prevention (CDC) has been saying that COVID-19 vaccines are safe and effective, and severe side effects are rare. The agency also says that all children aged 5 and older should get Pfizer’s vaccine, and all children between the ages of 12 and 17 should get a booster.
However, recent studies have found that Pfizer’s COVID-19 vaccine doesn’t do well in preventing infection against the Omicron variant for children 5 to 15 years old.
McCullough pointed out that it would be unnecessary to get young children vaccinated because most of them have already contracted the virus.
“We’ve heard reports recently from the CDC that roughly 75 percent of children have already had COVID. So for them, it’s too late for any hope of a vaccine. The vaccine can’t help once somebody’s already had COVID,” McCullough said, adding that if a vaccine doesn’t have at least 50 percent coverage, it would be considered “nonviable.”
On April 26, an early release of CDC’s Morbidity and Mortality Weekly Report said that about 75 percent of children and adolescents had already developed antibodies against the disease.
McCullough said COVID-19 has become “progressively” milder through its progression of mutations and the Omicron variant caused much fewer hospitalizations or deaths.
A number of studies have found that the clinical severity of infection is much lower for Omicron than for the Delta variant. In March, a peer-reviewed study published in Lancet is the largest one to date, which analyzed data from 1.51 million COVID-infected people in England between November 2021 and January 2022. Among them, over 1.06 million were infected by Omicron.
The study found that the overall risk of hospitalization within the 14 days after a positive test was 1.64 percent with Delta and 0.9 percent with Omicron. The mortality risk in the 28 days after a positive test was 0.27 percent after Delta, falling to 0.11 percent after Omicron.
“I can tell you, we have studies now, large studies on Omicron, where there’s close to zero hospitalizations or deaths,” said McCullough. “It’s essentially a common cold.”
The Epoch Times has contacted FDA, Moderna, and Pfizer for comments.
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FDA: Americans Should Treat COVID-19 Like the Flu
Several top Food and Drug Administration (FDA) officials, including Commissioner Robert Califf, admitted that Americans will now have to accept COVID-19 as another respiratory virus, comparing it to influenza.
Califf, Principal Deputy Commissioner Janet Woodcock, and top vaccine official Dr. Peter Marks wrote for the Journal of the American Medical Association that COVID-19 will be around for the foreseeable future while suggesting that it will require yearly vaccines targeting the most threatening variations of the virus.
“Widespread vaccine- and infection-induced immunity, combined with the availability of effective therapeutics, could blunt the effects of future outbreaks,” the officials said, referring to another name for the CCP (Chinese Communist Party) virus. “Nonetheless, it is time to accept that the presence of SARS-CoV-2, the virus that causes COVID-19, is the new normal.”
The virus “will likely circulate globally for the foreseeable future, taking its place alongside other common respiratory viruses such as influenza. And it likely will require similar annual consideration for vaccine composition updates in consultation with the [FDA],” they continued.
It’s a departure from the rhetoric that was expressed by public health officials in 2020 and 2021. In late October 2020, for example, current White House COVID-19 adviser Anthony Fauci said that President Donald Trump’s comparisons to the flu were false, telling NBC at the time “it is not correct to say it’s the same as flu.”
About a year later, Fauci told CBS News that Americans will “likely” have to deal with COVID-19 in a similar manner as influenza. “That’s entirely conceivable and likely, as a matter of fact, we are not going to be in a situation of this degree of intensity indefinitely,” he said when asked about the Omicron variant.
Data published by the U.S. Centers for Disease Control and Prevention (CDC) shows that while cases have trended slightly upward in the United States, the numbers are a fraction of the cases that were reported in mid-January when the seven-day average stood at around 800,000 per day. As of May 6, the seven-day average was about 68,000 per day.
In the Journal of the American Medical Association article, the three FDA officials proclaimed that by the summer of 2022, decisions will have to be issued “about who should be eligible for vaccination with additional boosters and regarding vaccine composition.”
“Administering additional COVID-19 vaccine doses to appropriate individuals this fall around the time of the usual influenza vaccine campaign has the potential to protect susceptible individuals against hospitalization and death, and therefore will be a topic for FDA consideration,” they added.
https://www.theepochtimes.com/fda-americans-should-treat-covid-19-like-the-flu_4453370.html
********************************************When Biden’s own people don’t trust him to speak, we have no real president
There is nothing more symbolic of American political power than a president of the United States holding court in the Oval Office.
Ensconced in that intimidating room, countless leaders have browbeaten, charmed, and cracked wise with the powerful and the press for generations.
But not Joe Biden.
And now we know why. According to new reporting, the reason we don’t see Joe in the Oval very often is that his team can’t install a teleprompter to keep the gaffer-in-chief on script.
So yeah, that’s where we are regarding the leader of the free world.
If one really stops and thinks about this it is simply shocking. The primary job of any politician, but especially a president, is to communicate a vision of policy and competency to the American people and the people of the world.
We have a president today who is incapable of this most basic element of his job. And whatever unelected group of White House flunkies there are — who are actually the president — can’t trust him to even open his mouth unless he can stare at a teleprompter and mouth their insights like the weatherman.
Things have gotten so obvious and awkward of late that even when Biden does have his trusty large print screen scrolling his supposed ideas he can’t even push them out. His struggle with the word “kleptocracy” in recent remarks was just sad. And fine, he grew up with a stutter, but he’s been in the public spotlight since “The Godfather” was in movie theaters.
The darkest and most troubling possibility here, but one we must face, is that we functionally have no actual President of the United States. If he can’t appear in public, in his own office, for want of a digital cheat sheet, then of course he has little if anything to do with the actual running of the country. And he’s not even a good false figurehead — using the teleprompter he often looks and sounds like he’s reading the bottom line of the eye exam.
Let’s face it. Even for an administration that thinks it’s a TV show, the construction of a White House set where Biden can wax incoherently was bizarre. But now we know this sound studio was set up to protect Biden, as much as possible, from his own words and actions. Maybe soon the president will only do live events in virtual reality where his handlers can correct his errors in deep fake real-time. Why not have the president be a programmed hologram? Is that so different from the current reality?
It’s time to talk about grandpa. He probably shouldn’t be driving or using the gas oven on his own anymore, or, you know, running the most powerful country on the planet into the ground.
Maybe the White House will overcome the great technical challenges of getting a screen with words on it into the Oval Office and we can once again see a president in his actual, natural environment. But given that this administration has given no indication in 20 months that it can even tie its shoes, I suggest we don’t hold our breath.
Pay no attention to the man behind the curtain, the wonderful Wizard of Ahs and Ums. Just go along with the joke as the Democrats would have us do. But the joke isn’t funny anymore. A president who cannot even give brief remarks in the Oval Office is no president. And that, my friends, is that sad fact.
So what are we going to do about it?
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
https://immigwatch.blogspot.com/ (IMMIGRATION WATCH)
https://awesternheart.blogspot.com/ (THE PSYCHOLOGIST)
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